This invention relates to intravascular devices for insertion into a blood vessel through an opening in the wall of the blood vessel. More particularly, this invention relates to intravascular devices incorporating a mesh reinforcement for structural integrity.
Intravascular seals may be inserted into blood vessels in a variety of procedures that require formation of a connection (anastomosis) between a bypass graft and donor or recipient blood vessel. The seals may be used during the procedure to maintain vessel integrity while the procedure is occurring.
Typically, an occlusion assembly is provided for sealing puncture openings. After puncturing a blood vessel with a needle and introducer sheath and subsequent withdrawal of the needle, the occlusion device can be inserted into the vessel via the introducer sheath. The occlusion device comprises a device that is attached to a retaining element such as a thread. In the blood vessel, it unfolds to have a surface area, which is larger than the surface area of the puncture opening to be occluded.
Subsequently the introducer sheath is removed out of the opening in the vessel and by pulling the retaining thread, the sheet material of the occlusion element will come to lie against the inside of the blood vessel wall. Thereafter, a retainer ring is placed around the thread and engages with the outer surface of the blood vessel for a fixed positioning of the occluding device. The device, the thread and the retainer ring are made of bio-absorbable material such that it is ensured that after the opening in the blood vessel has been occluded, these parts will disappear, for example after a few weeks.
Another type of intravascular seal is described in WO99/08603, assigned to Medtronic, Inc. This seal may be inserted into and subsequently retrieved from a blood vessel through an opening in the wall of the vessel. After completion of the anastomosis, the seal can be retrieved from the recipient vessel. Upon retrieval the sheet material is folded when it is contacted by the sides of the opening in the vessel wall.
The above seals must be flexible in order to be inserted into the blood vessel properly. However, if the seals are too flexible, they may not maintain the desired shape to ensure sealing of the vessel. Additionally, if the gripping element of the seal is not an easily graspable mechanism, it may be difficult to remove the seal because the gripping element will slip out of the users hands. Moreover, if the seals are too flimsy, they may rip while being retrieved from the vessel, particularly in the segment where the gripping element is attached to the seal.
It would be desirable therefore to provide an intravascular seal with desired flexibility that still maintains its desired structural integrity.
It would also be desirable to provide an intravascular seal to which an easily graspable gripping element may be securely attached.
It would also be desirable to provide an intravascular seal that may be easily inserted and retrieved.
One aspect of the present invention provides an intravascular device. The device comprises a sealing member, the member including a mesh material and a gripping element operatively attached to the sealing member, the gripping element operatively adapted to allow a user to position the sealing member to seal a blood vessel. The mesh material may comprise a plurality of mesh strands. The gripping element may comprise a tether. The tether may be attached to at least one of the mesh strands. The mesh material may form a grid pattern that may be used to measure a length of an incision. The gripping element may be a tube with a channel formed therein and at least one thread contained within the channel. The sealing member may have an oval shape, may be curled to facilitate insertion into a blood vessel, may be thinner near its perimeter than near its center, may have increased stiffness along its length, may be made of a non-biodegradable material, may be made of a deformable sealing material, or may be foldable for placing the sealing member into an insertion configuration and unfoldable to contact a blood vessel wall in a sealing configuration.
Another aspect of the present invention provides a device for insertion into a blood vessel through an opening in the wall of the vessel. The device comprises a flexible sealing member adapted to fold into an insertion configuration, a mesh material integrated with the sealing member; and a gripping element operatively attached to the sealing member. The gripping element may be attached to the mesh material. The mesh material may comprise a plurality of mesh strands. The gripping element may be attached to at least one of the mesh strands. The sealing member may comprise at least two membranes, the membranes sealingly connected along their perimeter. The device may also include a supply duct for supply of a fluid into a space between the membranes for inflating and deflating the device.
Another aspect of the present invention provides a method of measuring a length of an incision in a blood vessel. An intravascular sealing device is provided comprising a sealing member having a mesh material formed in a grid pattern and a gripping element operatively attached to the sealing member. The length of the incision is measured using the grid pattern.
Another aspect of the present invention provides an intravascular device. The device comprises a gripping element, including a channel formed therein, the channel operatively adapted to contain at least one thread therein, a sealing member operatively attached to an end of the channel; and at least one thread operatively attached to the sealing member so that a movement of the thread causes the sealing member to change configuration. The sealing member may include a mesh material. The mesh material may comprise a plurality of mesh strands. The thread may be attached to at least one of the mesh strands. The movement of the thread may be a pulling movement. The sealing member and the gripping element may be formed in one piece. The device may also include a rigid guide including a channel operatively adapted to receive the gripping element therein. A plurality of threads may be attached to the sealing member such that a movement of the threads causes the sealing member to change configuration. The sealing member may fold in a parachute configuration. The sealing member may change configuration to an insertion configuration for insertion into a blood vessel. The sealing member may change configuration to a sealing configuration. The sealing member may change configuration to an insertion configuration with a first movement of the thread and change configuration to a sealing configuration with a second movement of the thread. The sealing member may be inserted into the blood vessel in an insertion configuration and change configuration to a sealing configuration within the blood vessel.
Another aspect of the present invention provides a method of connecting two blood vessels. An intravascular device is provided having a sealing member including a mesh material; and a gripping element operatively attached to the sealing member. A recipient vessel is opened. The device is inserted into the recipient vessel in an insertion configuration. The configuration of the device is changed to a sealing configuration. The blood in the vessel is allowed to flow through the recipient vessel and past the device. A second vessel is partly attached near the opening in the recipient vessel. The device is removed from the opening. The second vessel is completely attached to the recipient vessel.
The foregoing, and other, features and advantages of the invention will become further apparent from the following detailed description of the presently preferred embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention rather than limiting, the scope of the invention being defined by the appended claims in equivalence thereof.